Note: Counseling and informed consent are recommended for genetic testing. A consent form is available as a resource but not required.

INTERPRETATIVE DATA:

Incidence: About 85% of lung cancers are nonsmall cell lung cancers (NSCLC); and of them, about 10% of those individuals have EGFR mutations. These individuals respond rapidly and dramatically to therapy with Gefitinib.

Molecular Genetic Mechanism: Somatic mutations can be point mutations or insertions and deletions.

Clinical Sensitivity: The tissue sample submitted for testing must contain at least 30% tumor. The assay will detect a 25% population of mutant cells.

Analytical Sensitivity: 75%

Test Limitations: Mutations located outside of the exons examined by sequencing. This test is only for somatic EGFR mutation in cancer tissue. Rare diagnostic errors can occur due to primer / probe site mutations or rare polymorphisms.

INDICATIONS FOR USE:

To determine whether a nonsmall cell lung cancer in a patient may be responsive to therapy.